RESUMEN
OBJECTIVE: The aim of this study was to assess the efficacy and safety of a single intravenous (i.v.) bolus of dexketoprofen trometamol compared with an i.v. infusion of dipyrone in patients with moderate to severe pain due to renal colic. METHODS: A total of 308 patients with renal colic and visual analog scale (VAS) score >/=40 mm participated in a multicenter, randomized, double blind, double-dummy, parallel, and active-controlled study and were randomized to dexketoprofen 25 mg (n = 101), dexketoprofen 50 mg (n = 104), and dipyrone 2 g (n = 103). RESULTS: Mean [+/- standard deviation (SD)] total pain relief (TOTPAR) scores were similar in the dexketoprofen 50 mg (15.3 +/- 8.6) and dipyrone (15.5 +/- 8.6) and slighly higher than in dexketoprofen 25 mg (13.5 +/- 8.6), although significant differences were not achieved. In the same way, patients in the dexketoprofen 50 mg and dipyrone groups showed higher scores in the sum of pain intensity differences (SPID) and the sum of analogue pain intensity differences (SAPID) than patients in the dexketoprofen 25 mg group, reaching statistical significance in comparison with dexketoprofen 25 mg and dipyrone for SPID and SAPID (p < 0.05). The time-effect course for pain intensity differences and pain relief showed significantly higher values for both doses of dexketoprofen during the first 30 min after drug administration (p < 0.05). Dexketoprofen 50 mg and dipyrone groups had 66% and 70%, respectively, of patients with at least 50% of maximum obtainable TOTPAR in comparison with 56% in the dexketoprofen 25 mg group. The study medications were well tolerated. CONCLUSIONS: Dexketoprofen 50 mg administered as a single i.v. bolus was effective for the relief of moderate to severe pain in patients with renal colic, with a good safety profile and efficacy similar to i.v. dipyrone 2 g. Dexketoprofen produced analgesia that was faster in onset.